Guidelines | Policies | Rules

Recombinant DNA Safety Guidelines, 1990


Department of Biotechnology had formulated Recombinant DNA Guidelines in 1990. These guidelines were further revised in 1994, which included guidelines for R&D activities on GMOs, transgenic crops, large-scale production and deliberate release of GMOs, plants, animals and products into the environment, shipment and importation of GMOs for laboratory research. The issues relating to genetic engineering of human embryo, use of embryos and fetuses in research and human germ line, and gene therapy areas have not considered while framing the guidelines.

For research activities, the guidelines have been classified into three categories. Based on the level of the associated risk, requirement for the approval of competent authority is envisaged. Category I activities include those experiments involving self cloning using strains and also inter-species cloning belonging to organism in the same exchanger group which are exempt for the purpose of intimation and approval of competent authority. Category II activities which require prior intimation of competent authority and include experiments falling under containment levels II, III and IV (details of each containment level provided separately in the guidelines). Category III activities that require review and approval of competent authority before commencement include experiments involving toxin gene cloning, cloning of genes for vaccine production, and other experiments as mentioned in the guidelines. The levels of risk and classification of the organisms within these categories have been defined in these guidelines. Appropriate practices, equipment and facilities necessary for safeguards in handling organisms, plants and animals in various risk groups have been recommended. The guidelines employ the concept of physical and biological containment and the principle of good laboratory practices. For containment facilities and biosafety practices, recommendations in the WHO laboratory safety manual on genetic engineering techniques involving microorganisms of different risk groups have been incorporated therein.

For large scale experiments, the guidelines categorize experiments beyond 20 liters capacity for research and industrial purposes as large-scale experiments/operations. In case of plants, this limits is beyond 20 acres area. The guideline gives principles of occupational safety and hygiene for large-scale practice and containment. Safety criteria have also been defined in the guidelines. Physical containment conditions that should be ensured for large-scale experiments and production have been specified in the guidelines.

For release to the environment the guidelines specify appropriate containment facilities depending on the type of organisms handled and potential risks involved. The guidelines require the interested party to evaluate rDNA modified organism for potential risk prior to application in agriculture and environment like properties of the organism, possible interaction with other disease causing agents and the infected wild plant species. An independent review of potential risks should be conducted on a case-to-case basis.

Revised Guidelines for Research in Transgenic Plants and Guidelines for Toxicity and allergenicity evaluation of Transgenic Seeds, Plants and Plant Parts, 1998

These guidelines covers areas of recombinant DNA research on plants including the development of transgenic plants and their growth in soil for molecular and field evaluation. The guidelines also deal with import and shipment of genetically modified plants of research use.

As per the guideline, a special Monitoring cum Evaluation Committee (MEC) has been set up by the RCGM to monitor over a period of time, the impact of transgenic plants on the environment.

Guidelines for Generating Pre-clinical and Clinical Data for rDNA Vaccines, Diagnostics and Other Biologicals, 1999

Department of Biotechnology has issued a set of guidelines for preclinical and clinical evaluation of rDNA vaccines, diagnostics and other biologicals in 1999 to help in the production of relevant data for submission to Drug Controller General of India. The guidelines specially are on safety, purity, potency and effectiveness of the project.